- In SELECT-SUNRISE study, upadacitinib met the primary endpoint of ACR20 (An ACR20 score means that a person's RA has improved by 20%) across all doses (7.5 mg, 15 mg, 30 mg, once-daily) at... read more
Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), announced on 4/24/18 that new twelve-month data from its PROMISE 1 Phase 3 clinical trial in episodic migraine patients. The data demonstrated that... read more
Mirati Therapeutics, Inc. (Nasdaq: MRTX) (the Company or Mirati), On 4/24/18 provided a progress update on its lead development programs and announced updated, positive clinical trial data for... read more
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He... read more
Pfizer received a Complete Response Letter from the FDA on 4/23/18 highlighting the need for additional technical information. Though this is a setback for Pfizer's Herceptin biosimilar program,... read more